TABLE IV

Overpressure Results (≥1500 mbar) of Viral Vaccine Product Vials Stored at Different Temperature Conditions

ProductStorageNumber of Vials with Overpressure
Batch 1−80 °C7 out of 10
−80 °C/dry ice27 out of 74
Batch 2−80 °C/dry ice5 out of 25
Batch 3+5 °C0 out of 10
−20 °C0 out of 10
−80 °C0 out of 35
−80 °C/dry ice1 out of 25
Batch 4−80 °C/dry ice2 out of 98